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No eligible participants for the RCT were found
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| Name | Class |
|---|---|
| Universidade Estadual Paulista - UNESP | UNKNOWN |
| Universidade de Guarulhos | UNKNOWN |
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The aim of this study is to assess if hypogonadic men with periodontitis benefit from testosterone replacement therapy before being submitted to periodontal treatment. Fifty hypogonadic men (Total Testosterone <200ng/dL) will be recruited from the Clinics Hospital at Federal University of Paraná and subjected to periodontal evaluation by a trained and calibrated researcher. The subjects presenting with periodontitis (assessed by clinical parameters) will be randomly allocated to "testosterone replacement therapy" (TRT) group or "placebo" for 3 months. After that time, all patients will receive nonsurgical periodontal treatment, which will be reassessed after 45 days. Clinical parameters (such as probing depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub gingival plaque and gingival crevicular fluid will be collected at baseline, just before therapy and 45 days after therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Gel, daily |
|
| TRT | Experimental | Testosterone Replacement Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone gel | Drug | Androgel (50mg testosterone), gel, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| CAL | Clinical Attachment Loss | 4.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| PPD | probing pocket depth | 4.5months |
| PPD | probing pocket depth | 3months |
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Inclusion Criteria: total testosterone <200ng/dL in two assessments; at least 20 teeth present.
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Exclusion Criteria: systemic diseases such as hormonal, inflammatory and immune alterations.
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| Name | Affiliation | Role |
|---|---|---|
| Joao P Steffens, PhD | UFPR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica de Odontologia da Universidade Federal do Paraná | Curitiba | Paraná | 80210170 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26450018 | Background | Steffens JP, Coimbra LS, Rossa C Jr, Kantarci A, Van Dyke TE, Spolidorio LC. Androgen receptors and experimental bone loss - an in vivo and in vitro study. Bone. 2015 Dec;81:683-690. doi: 10.1016/j.bone.2015.10.001. Epub 2015 Oct 9. | |
| 26062840 | Background | Steffens JP, Wang X, Starr JR, Spolidorio LC, Van Dyke TE, Kantarci A. Associations Between Sex Hormone Levels and Periodontitis in Men: Results From NHANES III. J Periodontol. 2015 Oct;86(10):1116-25. doi: 10.1902/jop.2015.140530. Epub 2015 Jun 11. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007006 | Hypogonadism |
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"Placebo" and "TRT" groups
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Placebo
| Placebos | Drug | Placebo, gel, daily |
|
| BOP |
bleeding on probing |
| 3months |
| BOP | bleeding on probing | 4.5months |
| Micro-organisms concentration | DNA hybridization - checkerboard | 4.5months |
| Micro-organisms concentration | DNA hybridization - checkerboard | 3months |
| Concentration of inflammatory markers in crevicular fluid | Multiplex assay | 3months |
| Concentration of inflammatory markers in crevicular fluid | Multiplex assay | 4.5 months |
| 16805680 | Background | Daltaban O, Saygun I, Bolu E. Periodontal status in men with hypergonadotropic hypogonadism: effects of testosterone deficiency. J Periodontol. 2006 Jul;77(7):1179-83. doi: 10.1902/jop.2006.050286. |
| D006058 |
| Gonadal Disorders |
| D004700 | Endocrine System Diseases |